Evidence map›Paper›PMID 40114144›Full record

ArticleBMC cancer2025

Efficacy and safety of TQB2450 combined with anlotinib as maintenance therapy for LS-SCLC after definitive concurrent or sequential chemoradiotherapy: a prospective phase Ib study.

Xiaoli Liu, Xiaoyan Yin, Lulu Zhuang, Junxu Wen, Zhonghui Wei, Wenxing Cui, Minghao Yu, Kaikai Zhao, Lanping Liu, Lingling Kong and 7 more

2 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05942508 phase1unknown statusnot on this map

An Open, Single Arm, Single Center Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited Stage Small Cell Lung Cancer Without Progression After First-line Radiotherapy and Chemotherapy

TypeinterventionalSponsorJinming YuRan2023 to 2026Enrolled20ConditionsLimited Stage Small Cell Lung Cancer, Not Progressed After First-line ChemoradiotherapyArmsTQB2450 Injection + Anlotinib Hydrochloride Capsules
NCT06469879 phase3not yet recruitingnot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited-stage Small Cell Lung Cancer

TypeinterventionalSponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.Ran2024 to 2026Enrolled358ConditionsSmall Cell Lung Cancer Limited StageArmsTQB2450+Anlotinib, TQB2450 placebo + Anlotinib placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Xiaoli LiuCheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China.
Xiaoyan YinDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Lulu ZhuangCheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China.
Junxu WenDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Zhonghui WeiCheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China.
Wenxing CuiDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Minghao YuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Kaikai ZhaoDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Lanping LiuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Lingling KongDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Liyang JiangDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Xuquan JingDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Hui ZhuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences, Jiyan Road 440, Jinan, Shandong, 250117, China.
Xunqiang WangChia Tai Tianqing Pharmarceutical Group Co., Ltd., Nanjing, 211122, China.
Xinjun DongChia Tai Tianqing Pharmarceutical Group Co., Ltd., Nanjing, 211122, China.
Jinming YuCheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China. sdyujinming@126.com.
Xiangjiao MengCheeloo College of Medicine, Shandong University, Jinan, Shandong, 250012, China. mengxiangjiao@sina.com.

Funding

National Natural Science Foundation of China 82272845Natural Science Foundation of Shandong Province ZR2023LZL001
6 · The paper itself

Abstract

purposeThere is a significant unmet need in treating patients with limited-stage small-cell lung cancer (LS-SCLC). The ETER701 study showed that Benmelstobart (TQB2450, an anti-PD-L1 antibody) combined with Anlotinib and chemotherapy achieved the longest progression-free survival (PFS) and overall survival (OS) as a first-line therapy in patients with extensive-stage small cell lung cancer (ES-SCLC). This suggests that TQB2450 and Anlotinib represent a promising treatment combination for LS-SCLC. This prospective study aimed to evaluate the efficacy and safety of TQB2450 combined with Anlotinib as maintenance therapy for LS-SCLC following concurrent or sequential chemoradiotherapy (CCRT or SCRT).

methodsPatients who did not show disease progression after chemoradiotherapy were enrolled. They received TQB2450 and Anlotinib every 3 weeks for up to 24 months. TQB2450 was intravenously administered at a dose of 1200 mg every 3 weeks. Anlotinib was initiated at a dose of 8 mg daily for days 1-14; if well tolerated, the dose was increased to 10 mg. Adverse events (AEs) were recorded using electronic data capture system. The trial was registered at the ClinicalTrials.gov (NCT05942508, 06/07/2023).

resultsFifteen patients were enrolled in the study between May 31, 2023 and October 13, 2023. As of October 31, 2024, the median follow-up time was 15.13 months. The 12-month PFS rate was 86.7% (95% CI, 71.1-100.0), and the OS rate at 12 months was 100%. The disease control rate was 100%. AEs were reported in 13 patients (86.67%), with fatigue being the most common treatment related AE (40.00%). And two SAEs were observed (elevation in cardiac troponin T and cerebral infarction), which were determined to be unlikely unrelated to the trial drugs. Radiation pneumonitis (RP) occurred in three patients, all classified as grade 2, and one patient developed grade 1 immune-related pneumonitis. No grade 5 AEs occurred, and no patients withdrew from the study due to AEs.

conclusionsTQB2450 combined with Anlotinib showed promising efficacy and well tolerance in patients with LS-SCLC following first-line treatment. A randomized, double-blind, placebo-controlled Phase III clinical study (ClinicalTrials.gov Identifier: NCT06469879) is being conducted to further explore the efficacy and safety of TQB2450 combined with Anlotinib as maintenance therapy after definitive CCRT or SCRT for LS-SCLC.

trial registrationClinicalTrials.gov Identifier: NCT05942508. Date of registration: 7 June 2023.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIndolesLung NeoplasmsQuinolinesSmall Cell Lung CarcinomaAdultAgedChemoradiotherapyFemaleHumansMaintenance ChemotherapyMaleMiddle AgedProspective StudiesTreatment OutcomeanlotinibIndolesQuinolinesAnlotinibCombined drug therapyEfficacyLimited-stage small cell lung cancerSafetyTQB2450

Identifiers

PMID40114144
PMCPMC11924736

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.